Decreasing Wound InfectionNCT04006067
The Impact of Changing Gloves During Cesarean Section on Post-operative Wound Complication
A study testing changing surgical gloves in people with Decreasing Wound Infection, run by khalid abd aziz mohamed at 1 site in Saudi Arabia.
Trial summary
The investigators aim to compare the effect of changing their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure versus no intervention in the incidence of postoperative wound infections in pregnant women undergoing Caesarean section. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Decreasing Wound Infection
- What is being tested?
- changing surgical gloves
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Jun 2019to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Both elective and emergency cesarean sections.
- Patient received standard antibiotic prophylaxis within two hours from the procedure or during the procedure in emergency case.
Who cannot join
- Women with active infection during the procedure.
- Women did not receive the standard preoperative antibiotic prophylaxis.
- Women with diagnosis of chorioamnionitis.
Trial locations and contacts
1 site in 1 country.
ahmed morsi, MD contact
Saudi Arabia1 site, 1 recruiting
- Recruiting
AFHSR
Khamis Mushait
Khalid ibrahim, MD, 00966596984055
mohamed hussein, MD, 00966596984055
About this study
Official title: The Impact of Changing Gloves During Cesarean Section on Post-operative Wound Complication. A Single Blind Randomized Controlled Trial
The investigators aim to compare the effect of changing their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure versus no intervention in the incidence of postoperative wound infections in pregnant women undergoing Caesarean section. The primary outcome is the incidence of any post cesarean wound related complication, including wound seroma, skin separation of at least 1cm, wound infection, or other incisional abnormality requiring treatment within 8 weeks of surgery, while the secondary outcomes are Postoperative fever: defined as greater than 38 degrees Celsius or post cesarean endometritis: defined as a clinical diagnosis, usually involving fever, uterine fundal tenderness, or purulent lochia requiring antibiotic therapy or Combined wound complications and endometritis.
Read the detailed description
The investigators conduct a prospective randomized study at Department of Obstetrics and Gynecology, AFHSR since April 2019 till October 2019, after approval of the study protocol by the Local Ethical Committee.
Patients undergoing Both elective and emergency cesarean sections and Patients received standard antibiotic prophylaxis within two hours from the procedure or during the procedure in emergency case. All patients received appropriate pre-operative antibiotics, chlorohexidine skin prep except where allergies prohibited, and hair clipping as indicated.
The patients (600) are divided into two groups, Group A (300) during CS the surgical team change their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure, while in Group B (300) no intervention
- Conditions
- Decreasing Wound Infection
- Being tested
- changing surgical gloves
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
changing surgical glovesOther
All the surgical team including surgeons, surgical assists and scrub technicians replaced their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Other: changing surgical gloves |
| Group B | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of any post cesarean wound related complication
including wound hematoma, seroma, skin separation of at least 1cm, wound infection, or other incisional abnormality requiring treatment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start20 Jun 2019
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decreasing Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- khalid abd aziz mohamed
- Sponsor type
- University, hospital or other
- Collaborators
- Armed Forces Hospitals, Southern Region, Saudi Arabia
- Responsible party
- Sponsor-investigator, khalid abd aziz mohamed, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006067
- Sponsor's protocol ID
- khalid-shafik
- Status last verified
- Mar 2020
- First submitted
- 29 Jun 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will be shared later on
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Changing Gloves During Cesarean Section on Post-operative Wound Complication. A Single Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04006067
- Acronym / sponsor ID
- khalid-shafik
- Conditions
- Decreasing Wound Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- khalid abd aziz mohamedUniversity, hospital or other
- Collaborators
- Armed Forces Hospitals, Southern Region, Saudi Arabia
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to compare the effect of changing their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure versus no intervention in the incidence of postoperative wound infections in pregnant women undergoing Caesarean section. The primary outcome is the incidence of any post cesarean wound related complication, including wound seroma, skin separation of at least 1cm, wound infection, or other incisional abnormality requiring treatment within 8 weeks of surgery, while the secondary outcomes are Postoperative fever: defined as greater than 38 degrees Celsius or post cesarean endometritis: defined as a clinical diagnosis, usually involving fever, uterine fundal tenderness, or purulent lochia requiring antibiotic therapy or Combined wound complications and endometritis.
Detailed description
The investigators conduct a prospective randomized study at Department of Obstetrics and Gynecology, AFHSR since April 2019 till October 2019, after approval of the study protocol by the Local Ethical Committee.
Patients undergoing Both elective and emergency cesarean sections and Patients received standard antibiotic prophylaxis within two hours from the procedure or during the procedure in emergency case. All patients received appropriate pre-operative antibiotics, chlorohexidine skin prep except where allergies prohibited, and hair clipping as indicated.
The patients (600) are divided into two groups, Group A (300) during CS the surgical team change their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure, while in Group B (300) no intervention
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: changing surgical gloves |
| Group B | No intervention | – |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Both elective and emergency cesarean sections.
- Patient received standard antibiotic prophylaxis within two hours from the procedure or during the procedure in emergency case.
Key exclusion criteria (3 listed)
- Women with active infection during the procedure.
- Women did not receive the standard preoperative antibiotic prophylaxis.
- Women with diagnosis of chorioamnionitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| changing surgical glovesAll the surgical team including surgeons, surgical assists and scrub technicians replaced their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure. | Other | Group A |
Primary outcome
The incidence of any post cesarean wound related complication
Time frame: 8 weeks
including wound hematoma, seroma, skin separation of at least 1cm, wound infection, or other incisional abnormality requiring treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: Undecided. will be shared later on
Related trials for Decreasing Wound Infection
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 2
The Use of Tranexamic Acid in Decreasing Wound Complication in Total Ankle Replacement.
Ankle Arthritis, Wound Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmed morsi, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing changing surgical gloves in people with Decreasing Wound Infection, run by khalid abd aziz mohamed at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khalid ibrahim, MD (00966596984055, dr.khalidkhader77@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of any post cesarean wound related complication (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.